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January 29, 2018 | Author: Anonymous | Category: Science, Health Science, Immunology
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AIM-listed clinical stage biotech company

David Evans Dr Richard Goodfellow Professor Lindy Durrant

13th March 2012 1

Disclaimer This document is issued by Scancell Holdings plc (the “Company”), has been prepared solely for information purposes and is the sole responsibility of the directors of the Company. To the best of the knowledge and belief of the directors of the Company, who have taken all reasonable care to ensure that such is the case the information contained in this presentation is in accordance with the facts and does not omit anything likely to affect the import of such information. The dissemination of the information in these slides outside the United Kingdom may be restricted by law or regulations applicable in certain jurisdictions.

This presentation does not constitute or form, and should not be construed as constituting or forming, part of any offer or invitation to sell, or any solicitation of any offer to purchase or subscribe for, any securities in the Company or any other body corporate or an invitation or inducement to engage in investment activity under section 21 of the Financial Services and Markets Act 2000 nor shall it or any part of it form the basis of or be relied on in connection with any contract therefore. No reliance may be placed for any purpose whatsoever on the information contained in this presentation or on assumptions made as to its completeness. Some of the statements in the presentation represent the personal opinions of the directors of the Company. No representation or warranty, express or implied, is given by the Company or Zeus Capital Limited (“Zeus”), any of its subsidiaries or any of their respective advisers, officers, employees or agents, as to the accuracy, fairness or completeness of the information, opinions or statements based on the belief of the directors of the Company contained in this presentation or expressed in the presentation and no liability is accepted for any such information or opinions or statements based on the belief of the directors of the Company (which should not be relied upon) or for any loss howsoever arising, directly or indirectly, from any use of this presentation or its contents or information expressed in the presentation. This presentation is directed only at persons in the United Kingdom who fall within either Article 19 (investment professionals) or Article 49 (high net worth companies) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended). Persons who do not fall within either Article 19 or Article 49 should not rely on, or act upon, any information contained in this presentation. This document does not constitute an offer of securities in the United States. Shares of the Company may not be offered or sold in the United States without being registered under the United States Securities Act of 1933, as amended (“U.S. Securities Act”) or an available exemption from such registration. The Company does not presently intend to register any securities under the U.S. Securities Act and no public offering of shares is being or will be made in the United States. The information contained in this document is not for publication or distribution in, into or from the United States, Canada, Australia or Japan. Any failure to comply with these restrictions may constitute a violation of United States, Canadian, Australian or Japanese securities laws. This presentation contains forward looking statements which relate, inter alia, to the Company's proposed strategy, plans and objectives. Such forward looking statements involve known and unknown risks, uncertainties and other important factors beyond the control of the Company (including specific factors identified in this presentation and in our published Financial Statements) that could cause the actual performance, results, developments or achievements of the Company to be materially different from such forward looking statements. Accordingly, you should not rely on any forward looking statements and the Company accepts no obligation to disseminate any updates or revisions to such forward looking statements. By receiving this presentation you agree to be bound by the foregoing provisions.

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David Evans Non- Executive Chairman

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Dr Richard Goodfellow Co-Chief Executive

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Company Overview Clinical stage immunotherapy company with novel ‘ImmunoBody’ DNA vaccine platform for cancer and chronic infectious diseases Lead product (SCIB1 for melanoma) entered Phase I clinical trials in June 2010 with steady progress made in 2011 -Dose increased from 0.4mg to 4mg with no serious adverse effects Follow up vaccine targeting NY-ESO-1 (SCIB2) at pre-clinical proof of principle stage (lung, oesophageal, prostate, liver, gastric, ovarian, bladder cancers) with more in the pipeline Partnerships with Ichor Medical Systems, immatics Biotechnologies GmBH and others to optimise immune response and generate new products Antibody portfolio sale to Arana Therapeutics (now Cephalon/Teva) in 2006 Milestone payment of £2.85m received in November 2011 when SC104 started Phase 1 clinical trials in USA 5

Industry Trends Continued trend for Big Pharma to move away from in-house R&D and to rely more on partnerships with Industry and Academia Larger Biotechs becoming more aggressive buyers of innovative companies and providing growing competition for Big Pharma Pick up in M&A deal value in 2011 (e.g. Amgen/Biovex $1 billion) Public markets still generally unsupportive of early stage Biotech (until key value inflexion point reached) Outstanding projects with future strategic value to third party will succeed

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Cancer Vaccine Sales Increasing

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A Year of Steady Progress Patient recruitment for Phase 1 trial of SCIB1 in melanoma completed Dose escalation to highest dose of 4mg achieved with no serious adverse effects Follow up vaccine for lung and other cancers (SCIB2) produces outstanding results in animal studies Additional £1.73m (gross) raised in June 2011 Milestone payment of £2.85m received when SC104 entered clinical trials in November 2011 confirming commercial value of Scancell science Significant additional progress on technology platform Fully funded to completion of Phase 2 clinical trial

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Listing on AIM

Share Information

October 2011 Placing £1.58m raised

Share Price

Milestone payment of £2.85m from Cephalon Inc received

(10 for 1 Subdivision of Shares occurred 25 July 2011) Market Capitalisation at 1st January 2008- 2012

£1.6m raised in PLUS float

April 2010 Placing £2.5m raised

This data has been collated from information supplied by the London Stock Exchange, the PLUS Market and analyst research notes from the last four years

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Strategy on Track Validation of ImmunoBody platform through - Clinical data on SCIB1 - Phase 1 data 2012 - Phase 2 data 2013 -

Pre-Clinical data on new ImmunoBody vaccines

-

New supporting technologies

Trade sale to large pharmaceutical or biotech company

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Professor Lindy Durrant Co- Chief Executive

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SCIBI (melanoma) High avidity CD8 and CD4 response Better than synthetic peptide or whole antigen Better than DNA antigen immunisation

NH2 NH2

Similar to DC vaccines Works with gene gun, id/im electroporation Induces anti-tumour activity in vivo

COOH

GMP manufactured

KEY:

No Toxicity

gp100 DR4 epitope (L1 and H3) gp100 DR7,Dr53,DQ6 epitope (L3 and H1)

CTA May 2010 COOH

Clinical Trial June 2010

TRP-2 epitope (H2)

Metheringham et al., 2009 mabs 12

Ichor TRIGRID™ Delivery System Uses electrical fields to increase DNA drug delivery efficiency Electrode array consists of four electrodes in a diamond-shaped grid around a central injection needle Simple hand-held device developed for use in humans Can deliver equivalent does in man to mouse Im easier to deliver in humans than id Electrodes

Figure 2. Application Cartridge

Integrated Applicator

Injection Needle

Pulse Stimulator

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Phase I-II trial in stage IV/III melanoma Start: June 2010

Primary Objective: To demonstrate safety and tolerability

Secondary Objective: To demonstrate cellular immune response (high avidity T-cells) and tumour response

Phase One • • •

9 patients 3 subjects per cohort; 0.4mg, 2.0 mg or 4.0 mg Progression only if adequate safety demonstrated at previous dose

Phase Two • •

13 subjects Subjects to receive maximum tolerated dose provided no clear evidence of improved efficacy at lower doses

0

3wks

6wks

3 months

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6 months

Phase I-II trial in stage III/IV melanoma •

GTAC approval for the trial was given in May 2010 and the first patient was immunised in June 2010



5 centres: Nottingham, Manchester, Newcastle, Leeds and Southampton



Phase I fully recruited – no toxicity



Phase II starting 2 Q 2012



Phase I completed by end 2012



Phase II completed in 2013 with report in early 2014

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SCIB2-NYESO-1

1200

conrol

100

IB

av.spots/million splenocytes



Expressed by lung (SCLC), melanoma, oesophageal, liver, gastric, prostate, ovarian and bladder cancers Improves survival

90 80

P=0.044

%survival



• Vaccine encodes 20 epitopes covers 90-100% of population • Better than peptide • Better than Dc peptide (Dendreon)

70 60 50 40 30 20 10 0 5

days post tumour challenge 15 25

35

DNA peptide DC+peptide

1000 800

p=0.0041

600 p=0.0003 400 200 0 1E-10 0.001 1E-09 0.0001

-08 1E 0.01

-07 1E0.1

1E-06 1

1E-05 10

peptide conc (M)

In combination with homspera it completely inhibits tumour growth

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Candidate for SCIB3? • Novel patentable target (Patents being prepared) • Widely expressed ( lung , ovarian , renal, leukaemias, sarcomas, melanoma, oesophageal, liver, gastric and prostate cancers) • Novel CD4 self epitope stimulates killer CD4 T cells • Potent anti-tumour response conrol SCIB1 SCIB3

100 90

%survival

80 70 60 50 40 30 20 10 0 5

15

25

days post tumour challenge

35

45

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Summary • Phase I recruited • Phase II due to start April 2012

• SCIB2 NYESO-1 good anti-tumour response • SCIB3 new patent good anti-tumour response

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Appendix

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Board of Directors David Evans (Non-Executive Chairman) Guided Shield Diagnostics Ltd through IPO, and then through its merger with Axis Biochemical ASA to form AxisShield plc. Non-executive Chairman of Epistem Holdings plc, Omega Diagnostics Group plc and EKF Diagnostics Holdings plc, all AIM-listed biotech companies. Professor Lindy Durrant (Founder and Joint Chief Executive Officer) Founder of Scancell and internationally recognised immunologist in the field of tumour therapy, has worked for 20+ years in translational research, developing products for clinical trials including monoclonal antibodies for diagnostic imaging and therapy and cancer vaccines.

Dr Richard Goodfellow (Co-founder and Joint Chief Executive Officer) Key member of the Scancell management team since 1999, negotiating the 2006 Arana deal. 25+ years international experience in the pharmaceutical industry, both major pharma and smaller biotech companies: held key senior product launch and business roles at AstraZeneca and Scotia Pharmaceuticals, founder of Paradigm Therapeutics and former director of Enact Pharma plc.

Nigel Evans (Non-exec and Company Secretary) 40 years of commercial and strategic responsibilities at senior levels in Rolls-Royce plc in the UK and overseas. Previously chairman, he now oversees Scancell’s corporate and financial activities. Active investor in public and private companies.

Michael Rippon (Non-executive Director) 40+ years experience in the motor industry. Active investor in small private companies and one of Scancell’s major private investors. Appointed to the Board in 2004 as the Shareholder Representative.

Dr Matthew Frohn (Non-executive Director) Dr of Biochemistry, has worked on research collaborations with Astra Zeneca, and at a British biotech subsidiary before joining Oxford Technology Management in 1999. Manages Oxford Technology VCTs.

Kate Cornish-Bowden (Non-executive Director) A Chartered Financial Analyst, Kate was managing director and head of Morgan Stanley Investment Management’s Global Core Equity Team between 2002 and 2004. More recently, Kate has acted as a consultant providing financial research to private equity and financial training firms and was appointed a director of Investec Structured Products Calculus VCT plc in February 2011.

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Key Facts & Major Shareholders Ticker

SCLP

Stock Exchange

AIM

Shares in Issue

194m

Share Price

6.5p

HSBC Global Custody Nominee

13.00

Sector

Pharmaceuticals & Biotechnology

New Edge Group SA

9.04

Hygea VCT Plc

7.63

Professor Lindy Durrant

5.39

J G Helfenstein

5.38

Oxford Technology VCT

4.29

Share Nominees Ltd

3.48

Dr Richard Goodfellow

3.42

T Walthie

3.20

% of Issued Share Capital

Year ended 30.04.11

Year ended 30.04.2010

£

£

-

-

Operating Loss

(1,733,749)

(1,802,066)

Loss Before Taxation

(1,724,136)

(1802,639)

4,635,742

6,047,877

Revenue

Net (Liabilities) / Assets

Net cash outflow from operating activities

Net funds at 30 April

(1,842,219)

(1,504,392)

1,110,630

2,830,145

December 2011

*Oxford Technology Management Limited does not hold these Ordinary Shares directly but is the manager for the Oxford Technology VCT plc which holds 666,663 Ordinary Shares and Oxford Technology 3 VCT plc which holds 275,925 Ordinary Shares

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Glossary Antibodies

Proteins found in blood or other bodily fluids of vertebrates, used by the immune system to identify and neutralize foreign objects, such as tumours

Antigen

A molecule that is recognised by an antibody or T-cell receptor

Avidity

How strongly two cells interact

Dendritic cells

A type of white blood cell that initiates an immune response

Electroporosis

The process where cell membrane pores are opened through the application of electromagnetic fields. An electroporosis delivery system uses the electrical fields to increase DNA drug delivery efficiency by up to 1,000 fold

Epitope

A peptide that is recognised by a T cell

ImmunoBody

an antibody genetically engineered to express T cell epitopes from a tumour antigen

Immunotherapy

The use of the immune system to reject cancer. The patient's immune system is stimulated to attack the malignant tumour cells, either through immunization of the patient (eg. by administering a cancer vaccine), or through the administration of therapeutic antibodies as drugs

In vivo

In the body

Melanoma

A cancer which usually starts in either a mole or in normal-looking skin. About half of all melanomas start in normal skin. If the skin cells (melanocytes) receive too much ultraviolet light (through sunlight or tanning booths), the cells may begin to grow abnormally and become. cancerous Melanoma is the most serious type of skin cancer

Peptide

A string of amino acids

Secondary or metastatic

Cancer that has spread from its original site. Melanoma is highly metastic

T cell

Type of white blood cell that is composed of CTL and helper cells

Cytotoxic (CTL) Tcells

Type of white blood cell that recognises and kills tumour or virally infected cells

Helper T cell

Type of white blood cell that recognises and secretes molecules to alert the immune system to the presence of a tumour or virally infected cell

Translational medicine

It integrates research inputs from the basic sciences, social sciences and political sciences to optimise both patient care and also preventive measures which may extend beyond the provision of healthcare services

Vector

A molecule that encodes an epitope and targets the immune response

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